BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    MY01 Continuous Compartmental Pressure Monitor

    FDA 510(k)
    FDA Unclassified ·Unknown

    Anti-D (RH1) IgM

    FDA UDI
    DIAGAST·23661562105254·Blood Grouping Reagent, Anti-D (Human/Murine Mo...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180137332·5 MM DIA., 45 CM TACTILE PROBE WITH "CM" MARK

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756814287·RIGID COLLAR

    APPLE ECG (ELECTROCARDIOGRAPH) APP

    FDA Adverse Event
    Injury ·APPLE INC.·Product code QDA·July 5, 2023

    BD MICROLANCE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·August 25, 2021

    ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VITALOGRAPH MODEL 7100 - VITALOJAK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    P.F.C. CRUC SACR FEM SIZE-3

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·October 22, 2008

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·August 10, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 8, 2013

    BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·April 17, 2019

    Alinity m System, Part No. 08N53-002

    FDA Enforcement
    Class II ·Terminated·Abbott Molecular, Inc.·January 12, 2022

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025